An open-label, randomized, cross-over bioequivalence study of lafutidine 10 mg under fasting condition

Table 1 Mean pharmacokinetic parameters of the test and the reference formulations, each containing 10 mg lafutidine

Parameters	Test (mean ± SD)	Reference (mean ± SD)
Cmax (ng/mL)	265.15 ± 49.84	246.79 ± 29.30
AUC(0-t) (ng.h /mL)	1033.13 ± 298.74	952.94 ± 244.07
AUC(0-∞) (ng.h/mL)	1047.61 ± 301.22	964.22 ± 246.45
tmax (h)	0.95 ± 0.24	1.01 ± 0.29
Kel (h-1)	0.44 ± 0.19	0.42 ± 0.22
t½ (h)	1.92 ± 0.94	2.05 ± 1.05

AUC: Area under the curve.

Table 2 Ratio (Test/Reference), 90% confidence interval and intra-subject variation following the administration of 10 mg lafutidine tablets

Parameters	Ratio (Test/Reference, %)	90% Confidence interval (Log transformed data)	Intrasubject variability (Log transformed data, %)
Cmax	106.69	101.86-111.74	9.36
AUC(0-t)	107.90	102.25-113.86	10.88
AUC(0-∞)	108.14	102.56-114.03	10.73

AUC: Area under the curve.

Table 3 Individual pharmacokinetic parameters of lafutidine 10 mg tablets

Subject	Cmax (ng/mL)		tmax (h)		AUC(0-∞) (ng.h/mL)		t½(h)
No.	T	R	T	R	T	R	T	R
1	251.39	206.84	0.75	2.00	832.06	739.16	2.10	1.86
2	262.45	177.45	0.75	0.75	710.95	488.76	0.76	1.41
3	296.14	261.31	1.25	1.25	1194.42	1216.98	2.15	2.38
4	437.81	329.52	1.00	1.25	1794.64	1616.96	2.66	2.04
5	272.06	266.29	0.50	1.00	1514.49	1362.13	3.88	5.33
6	226.16	211.52	0.75	1.50	817.78	826.44	4.66	3.49
7	333.21	262.45	1.50	1.00	1670.60	919.94	2.74	2.38
8	367.03	284.66	1.00	0.75	1351.55	1029.20	2.83	2.60
9	217.84	264.98	0.75	0.75	915.96	946.37	1.47	1.17
10	239.84	263.04	0.75	1.00	908.95	955.31	1.68	2.17
11	261.86	230.72	1.00	0.75	934.60	1025.74	1.19	2.00
12	261.43	239.22	0.75	1.00	711.94	724.40	2.09	1.28
13	272.29	274.25	1.00	0.75	1079.63	1054.03	1.11	3.49
14	242.47	239.57	1.25	0.75	1338.51	1297.85	1.34	1.66
15	252.28	248.71	1.00	1.25	1132.98	1158.95	1.64	2.66
16	255.77	258.87	1.25	1.00	927.31	953.39	1.13	0.63
17	230.14	228.79	0.75	1.00	775.57	701.88	1.82	1.96
18	244.41	241.83	1.00	0.75	893.76	803.78	2.01	2.16
19	224.93	225.22	0.75	1.00	774.27	704.02	0.92	2.14
20	238.08	232.65	1.25	1.00	992.35	884.79	2.41	1.19
22	246.95	242.79	0.75	1.00	1109.70	1100.98	1.71	0.86
23	239.34	237.60	1.25	1.00	1163.50	984.41	0.95	1.31
24	240.45	245.86	0.75	1.00	727.85	825.47	1.32	1.01
26	249.33	248.84	1.00	0.75	869.33	820.28	1.42	1.97

T: Test formulation; R: Reference formulation; AUC: Area under the curve.